EUCTR2010-023510-32-BE进行中（未招募）1 期
A phase IV, randomised, double-blinded, placebo-controlled, parallel study to estimate the influence of vitamin D (D-CURE®) supplementation on the 25-hydroxyvitamin D serum concentration in patients aged over 50 years.
aboratoires SMB S.A.0 个研究点开始时间: 2010年12月1日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female over 50 years old (50 years inclusive);
- •Presenting a Body mass Index between 18 and 35 kg/m² inclusive;
- •Able to comply with all study procedures;
- •Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form;
- •If the patient is female and of childbearing potential, she must be using an efficient means of birth control, as determined by the investigator and provide a negative blood pregnancy test at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease;
- •Patients presenting a thyroid gland dysfunction;
- •UV light solarium use 2 weeks before the screening visit;
- •Use of drugs which may interfere with vitamin D metabolism e.g Phenobarbital, Phenytoin, glucocorticoids;
- •Past or current history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
- •Patients who present a vitamin D concentration > 60 ng/ml at screening;
- •Patients who have a serum creatinine > 150 µmol/L at screening;
- •Patients who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
- •Use of any of the prohibited medication as detailed in the concomitant medication section;
- •Participation in any other clinical trial within 2 months of the screening visit;
- •Travelling outside European countries during the study participation;
- •Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study;
- •Patients with any sensitivity or allergy to any of the products used within this clinical trial;
- •History of drug and/or alcohol abuse;
- •Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab).
研究者
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